- Device
- Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Mirro MRI DR ICD, M
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S748
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2020-09-29
- Decision code
- APPR
- Date received
- 2020-07-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for updates to the Model SW016, Model SW033, and Model SW022 programmer applications to update the H3 Battery Longevity Estimator functionality.